Medical Device Regulatory Experts from Finland

At Nometech, our team of medical device regulatory experts is dedicated to bridging the gap between innovation and compliance.  Our team consists of seasoned specialists in quality management and regulatory affairs who bring deep, hands-on experience to every project.
 
We specialize in navigating complex requirements. Such as ISO 13485, ISO 14971, the IEC 60601-1 series, FDA, and EU MDR 2017/745. Consequently, we understand how to align compliance, documentation, and regulatory strategy with your real-world development goals. This integrated approach ensures your products meet all regulatory expectations without adding unnecessary complexity to your daily operations.

Our Regulatory and Quality Management Experts

Our team of experts brings together diverse backgrounds in engineering, quality management, and regulatory science to solve the unique challenges of the medical device industry. Our team provides technical documentation review services to ensure global market access. By combining deep technical knowledge with a hands-on approach, we ensure that your product development remains compliant and efficient at every stage. We don’t just point out requirements; we work alongside you to implement them effectively. Consequently, you gain a dedicated partner committed to transforming complex regulations into a competitive advantage for your business.

Katja – Medical device quality and regulatory specialist at Nometech
Katja Koskinen

CEO and regulatory specialist

I hold a Master of Science degree in Electrical Engineering and have over 15 years of experience in medical device compliance and quality management. My work covers Medical devices verification and validation strategy,  ISO 13485, EU MDR, FDA QMSR, MDSAP, and ISO 9001 compliance, including documentation and certification. I have experience with internal audits, FDA submission documentation, and EU MDR technical documentation for CE marking, and I provide PRRC services to support continuous regulatory compliance.

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Sanna – Medical device regulatory and compliance expert at Nometech
Sanna Sillanpää

Quality engineer

I am a Quality Engineer with a clinical background as an optometrist and over ten years of experience in healthcare. I am currently completing master’s studies in Digital Health and Well-being. My work focuses on maintaining ISO 13485, FDA, and EU MDR compliant quality systems, including CAPA processes, internal and external audits, and quality system improvement initiatives. I am responsible for regulatory documentation management and support day-to-day quality system activities.

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